The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy when compared to a reference sham treatment in the treatment of patients who have undergone surgical intervention for chronic low back pain with or without a radiating lower extremity pain component.

Change From Baseline in Time-Averaged Pain Intensity Visual Analog Scale (VAS) Score [ Time Frame: Time-averaged from the first available observation to the last available observation (12 months for completed subjects) ] [ Designated as safety issue: No ]

Current use of another electrical stimulation device for low back or lower extremity pain

Current enrollment in another clinical trial within the last 30 days

Current or prior malignancy or cancer

Serious or uncontrolled systemic illness

Body mass index (BMI) greater than 40

Pregnant or intends to become pregnant during the study

Implanted medical device

Relationship with study staff

Unable to attend study office visits or complete study measures

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290238